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Director, Global Research - Amgen Inc.
Director, The Jenner Institute Nuffield Department of Medicine - University of Oxford
Lead, Clinical & Medical Operations, Global Clinical Management, IPDO - Dr. Reddy’s Laboratories
President and Chief Medical Officer - Alkem Laboratories Limited
Dayanand Sharma, a senior pharmaceutical professional, who is an M.D. & further trained in clinical research and Global Pharmacovigilance at Berkley Extension, California, USA and Management Forum, UK and Fellowship from Royal Liverpool Academy. Held various positions in leading multinational pharmaceutical companies for past 25 years, upto recently as Senior V.P. & Global Head & recent past as Chief Scientific officer. Associated as teaching faculty with various academic institutes internationally for areas related to drug development & clinical research, biomarkers, innovative drug development, pharmacovigilance, Medico-marketing & others. He has to his credit about 52 scientific & research publications, 47 patents and holds membership of International pharmaceutical society, American academy of dermatology, American Diabetes association, European society of respiratory medicine and executive founder member of an NGO called, “Health Alert Organization of India”.
Head – Technical - JNC MRS India
Executive Director & Emerging Science Lead (Asia & Asia Pacific) - Pfizer
Business Development Manager - Industrial Weighing Solutions - Mettler-Toledo
Partner Advisory Service - EY
Director - Bioprocessing Strategy Operationalization, Core & Novel Modalities - Merck Life Science
Regional Medical Director and Therapy Area Lead, Oncology, International Markets and Greater China Regions - Astellas Pharma
Medical affairs leader helping multinational pharma companies with scientific strategies and building medical affairs teams to bring new therapeutic options to treat patients' ailments and help in the overall business.
#Working towards building a "Future Fit" Medical Affairs. 10 years of progressive medical affairs experience and 5 years of team management experience. Have worked towards building strategic initiatives as well as execution of company medical strategies with Pharma majors like Astra Zeneca, Bristol Myers Squibb, Emcure and Astellas. Handled oncology portfolio for Sanofi, Novartis, and Roche as a part of Emcure Medical Affairs team. Known for my unbiased scientific communications and strategic thinking.
# Worked towards Launch Excellence of many first in class drugs in different therapeutic areas like Haemato-oncology, Hematopoietic Stem Cell Transplant/Bone marrow Transcplant, Oncology, Nephrology, Diabetes, Cardiovascular, Hepatitis, Urology and Immunology
#Served as Digital Champion(International Market) for "MA Center of Digital Excellence" for Astellas Global
# Managed the Medical Affairs team both as first and second line in the organization tree.
# Lead a regional training project for South East South Asian countries for Astellas
# Core member of Astellas Global Holistic Medical Education Project
#Lead the team to win "Best Medical Affairs Team Award 2019" in the Astellas Asia-Oceania Region.
Senior Vice President Clinical Research - Aurobindo Pharmaceuticals
Arani Chatterjee, MBBS, MPhil, PGCPM completed his graduation from CMC, Vellore and post-graduation from NIMHANS, Bangalore. He has a Post Graduate Certificate in Management from IIM, Indore. Before joining Aurobindo Pharma, he was Senior Vice President, Clinical Research at Biological E, Hyderabad for 3 years, Panacea Biotec, New Delhi for 9 years and Princpial Research Physician at Dr. Reddy’s Laboratories (Discovery Research), Hyderabad for 6 years. He has an experience of over 22 years, is a visiting faculty at University of Pune and Institute of Clinical Research, member of Expert Committee for PG Diploma in Clinical Research at IGNOU, Academic Board of Studies, Institute of Clinical Research, Hindustan Institute of Medical Sciences & Research, Sharda University and National Committee on Biotechnology of CII. He has served as a WHO Adviser for the Global Polio Eradication Initiative. He is a member of several Brighton Collaboration groups for vaccine safety. His has participated in WHO SAGE and GVSI meetings, pre-IND meetings with USFDA, scientific advice meetings with BfArM (Germany), ANVISA (Brazil), Medsafe (New Zealand), ALIMS (Serbia), expert group meetings on Indian GCP guidelines and Schedule Y, National Technology Advisory Group on Immunisation, Asia Pacific Dengue Prevention Board Meeting under the Pediatric Dengue Vaccine Initiative of International Vaccine Institute and Pneumococcal Vaccines at UNICEF. He has authored 22 papers in peer-reviewed journals and is a recipient of the 2012 Charles C. Shepard Award from CDC, Atlanta.
President Centre for R&D - IPCA Labs
He carried out his Ph.D. work at CDRI, Lucknow under the supervision of PadmashreeDr.NityaNand. This was followed by Post-Doctoral studies with Prof. Sir John Cornforth, a Chemistry Nobel Laureate, at the University of Sussex, England from 1981-1984.
He started his carrier with Alchemie Research Centre at ICI, Bombay in 1985 and served Lupin Laboratories before taking up the job with Ipca Laboratories Mumbai, a leading Pharma Company in the year 2000 and is presently heading the Centre for Research & Development of Ipca in the capacity of President.
He is a co-author in more than three dozen Papers published in peer reviewed International Journals, co-inventor in more than 100 patent applications filed, has presented scientific papers and keynotes in many National / International Conferences in addition to delivering invited talks on Biosimilars, R&D Management, Idea Management, Innovations, Role of Common Sense and Philosophy in Discovery / Research and many more such topics.
Scientist - Agilent Global Solution Development Center, Singapore
Professor of Pharmaceutical Sciences and the Director of the Bio- & Nano-Technology Center - University of Maryland School of Pharmacy
Site Head and Vice President- Operations - Lupin Limited (Biotech Division)
Chandrakant Kathote serves as a Site Head for Lupin’s Biologics facility at Pune, India. He is responsible for the Operations organization, which encompasses Manufacturing, MSAT, Engineering, Warehouse, Supply chain, Procurement, EHS, Finance.
Chandrakant has played Leadership roles in managing multi-site manufacturing operation for Drug substance, Drug Product and Devices through Mammalian and Microbial platform technology. Chandrakant has wide experience in large scale manufacturing of Biologics and small molecules, from clinical phase to commercialization in the US, EU and Japan. Chandrakant led several regulatory Inspections from US, EU, Japan and other geographies leading to successful approvals. He has gained significant understanding on process development, technology transfer, regulatory and quality requirements for Biologics manufacturing. To manage long term supply plans, he led several green field and brown field capacity expansion projects for Biologics and small molecules, including outside of India. Chandrakant Championed several Operational Excellence projects for Biologics and small molecules. He has significant experience in driving several cost reduction projects.
Chandrakant holds a Master’s degree in Bioprocess technology from Institute of Chemical Technology (erstwhile UDCT), Mumbai and completed on-campus Executive General Management Program from IIM Bangalore.
Associate Director of Biologics Discovery Department - GenScript Probio
Consultant- Technical - JNC corporation, Japan.
Senior Vice President-Business Development - Aurobindo Pharma Limited
Principal Scientist & Associate Professor-AcSIR/JNU - CSIR-Institute of Microbial Technology, Ministry of Science and Technology, Govt. of India
Executive Director, Custom Intelligence & Analytics [EMEAI] - Pharma Intelligence, Informa
Deputy Director, Office of Therapeutic Biologics and Biosimilars - FDA
Founder & MD - Bioinnovat Research Services Pvt. Ltd
Sr. Vice President & Head, Global Medical Affairs - Glenmark Pharmaceuticals
A Medical professional with specialization in M.D. Clinical Pharmacology with 18 years of Pharma/Biopharma experience; Currently working as Vice President & Head– Medical, Clinical & Regulatory affairs for Wockhardt, Mumbai; Earlier worked for Intas Pharma Ltd (15 years) & Alembic (2 years). He has Hands-on experience in the clinical development of Biosimilars, NCE, NDDS, Generics. He authored number of dossiers for NDA (new drug application), CTA (clinical trial application) & MA (marketing authorization) for biosimilars, NCE & NDDS products. Dr.Barkate has successfully developed and commercialized 12 biosimilars in India and has worked as Medical Lead for protocol development for biosimilars as per the advice of International regulatory agencies (EMA & US FDA). He is the invited speaker for conferences/ workshops on topics of clinical research, regulatory affairs, pharmacovigilance & biosimilar development at the different forum. He has No. of publications (10) in National & International journals.
Sr. Division Head - Medical Affairs & PVG - Otsuka Pharmaceutical India Pvt. Ltd.
Dr. Hemant Zaveri is a solution provider, strategist for oncology launches and have 16 years industry experience. He is part of the global core management team of Oncology apart from serving as regional lead for oncology pipeline.
Board Certified Pharmaceutical Physician with extensive Industry experience at Country, Regional and Global Level gained from the leading companies in the world. Detailed knowledge of Medical Affairs, Pharmacovigilance, Clinical Development and all relevant interfaces.
Have technical and critical analytical skills with fundamental principles of Oncology, adept at guiding the PMT & field force through interactive discussions and “practical” training approaches for better understanding of the concerned subject and product.
Excellent in time management and planning with interdisciplinary tasks in mind, working with end result in mind, self disciplined, strong organizer & motivator with a successful track record in executing from original concept through implementation to handle diverse specialty like, neuro-psychiatry, Urology, Oncology &orthopedics.
Involved in medical affairs pharmacovigilance activities for Otsuka Pharmaceutical India Pvt. Ltd.
Whole-time Director and CSO - Enzene Biosciences Ltd
Head of Upstream MSAT, APeC - Merck
Principal Secretary - Government of Telangana, Industries& Commerce (I&C) Department, &Information Technology, Electronics and Communications (ITE&C) Department
Senior Consultant, Core Modalities, Asia, Bioprocessing Strategy - Merck
Global Head and Vice President - Operations Strategy and Excellence and Digital - Dr. Reddy's Laboratories
Awarded as the Top 50 Quality professionals in India, Kulbhushan is a highly accomplished Business Transformation Leader, Astute Strategy deployment & Innovation practitioner with a proven track record of strategizing and implementing large scale Business Transformation in both Manufacturing and Service sector.
An alumni of GE's Operating Managers Leadership Program and Kellogg's Advanced Global Management Program, extensive Global Working Experience & Proficient in Innovations management, Supply Chain Re-engineering, Lean Six Sigma, Customer & Service Excellence.
With more than 20 Years of proven track record, Kulbhushan has held various leadership positions and successfully executed numerous strategic assignments globally. He has been credited with creating an Innovative Business transformation Model that creates a Robust Strategy Deployment framework (using Balanced Scorecard) translating the Vision of the Organization into High Impacting initiatives which are executed through structured methodologies of Innovation, Lean Six Sigma, TPM, Customer 360 and a host of Innovation tools and Digitization. He has enabled Millions of Dollars in tangible savings over the last two decades in Strategy, Business Excellence and Innovations.
He has led creation of Innovation labs aimed at creating digitization and exponential growth both in the Front end(Products / business model innovation) and back end (Process innovation) areas
Senior Analyst, Field Marketing - Beckman Coulter
Vice-President, Sr Global Program Head - Global Drug Development, Novartis
She works towards final accountability for the innovation, strategy, operations, and related development deliverables for Global Programs in Established Medicines within the Pain, Neuroscience & Psychiatry and Ophthalmology disease/clinical area.
She is responsible to lead a multidisciplinary team of functional experts focused on securing global regulatory approval, market access and optimized commercial value of the program while ensuring this is achieved with a high quality, full compliance to internal and external requirements within budget and in a competitive and timely manner, utilizing both the internal or other identified expert resources necessary for success. Also required to provide a strong and consistent support to the goals of the Development Leadership Team and to participate in critical development-wide management initiatives designed to shape the structure and processes.
Senior Vice President, Preclinical R&D - INOVIO Pharmaceuticals, Inc.
CEO - Zumutor Biologics
CSO - Polpharma Biologics
COO - Syngene International
BN, Managing Director & CEO - Stempeutics
Vice President & Head, Clinical R&D - Cipla
Internationally experienced industry physician (MD) and R&D leader with 20 years of experience in leading clinical development, clinical pharmacology, translational research, biopharmaceutics and preclinical functions in multinational pharma and academic
• Seasoned R&D professional, currently Head of Clinical R&D, responsible for clinical and preclinical development in a multinational pharma focussed on the development of complex generic and specialty products, including drug device combinations, in respiratory, pain, antimicrobial therapy area
• Formerly, Clinical Research Director and regional Head of Clinical/Clinical Pharmacology in global innovator pharma R&D responsible for global registration of NCEs/bio-better/ repurposed products in multiple therapeutic area- respiratory, oncology, infection, cardiovascular metabolic, dermatology and neurology
• Experienced member of committees responsible for Go/No-Go decision on phase transition and portfolio selection and chairman of Bio-council for Go/No-Go decision and scientific recommendation on developmental issues
• Successful collaboration experience and strong network with KOLs, AROs, CROs and solid understanding of global pharma R&D, organization, ecosystem and synergy potential
Head – Academics & Research - National Institute of Animal Biotechnology (NIAB)
Former Vice President – R&D - Biocon
Narendra Chirmule is the co-founder and CEO of SymphonyTech Biologics, a data analytics company focused on engineering solutions to biology. As former Head of R&D at Biocon (Bangalore), and leadership positions in Amgen (Thousand Oaks, CA) and Merck Vaccines (West Point, PA), has contributed to clinical development of vaccines and biopharmaceuticals. Dr. Chirmule completed his PhD on development of a leprosy vaccine, from Cancer Research Institute, Mumbai; post-doctoral studies on pathogenesis of AIDS from Cornell University Medical College-North Shore Hospital, New York. He has been teaching and conducting research as assistant professor in gene therapy at University of Pennsylvania, Philadelphia. Dr. Chirmule is on the NIH advisory committee for HIV vaccines.
Principal Scientist/Engineer, Downstream Processing - Pall Corporation
Founder, President & CEO - Geneos Therapeutics
Vice President, Viral Vaccine Manufacturing - Biological-E
Executive Director Business Development - Pall Corporation, UK
Senior General Manager- R&D - Aurobindo Pharma Ltd.
Senior Application Scientist, Cell and Gene Therapy (Asia Pacific and Japan) - Thermo Fisher Scientific
General Manager South Asia - Cytiva
Director & Head - Fortis Healthcare
Senior Adviser, Vaccine Delivery - Bill & Melinda Gates Foundation
Vice President & Head R & D - Indian Immunologicals Limited
Scientific Documentation & Compliance Team - Serum Institute of India, Ltd, Pune
Ms. Rajeshwari Adhiseshan holds a Masters degree (first class with distinction) in Pharmaceutical Sciences, from BITS, Pilani. She has over 20 years of industry experience that includes Sun Pharma, Dr. Reddys laboratories , and Biological E limited, in positions pertaining to Regulatory affairs, Clinical QA and Compliance. Presently, Ms. Rajeshwari Adhiseshan is heading the Scientific documentation and Compliance team at Serum Institute of India , Ltd, Pune.
Assistant Professor in Engineering Sciences - Institute of Chemical Technology (ICT)
CEO, Ingenuity Biosciences Pvt Ltd - Biosimilars Business Unit Head - Veeda Clinical Research | Bioneeds | Ingenuity BioSciences
Head – Vaccine Development Department - International Vaccine Institute (IVI)
M.Sc., Ph.D. (Virology), Director - Business Development – India - Bio-Works
Vice President Supply Chain Management - Dr. Reddy's Laboratories
SVP Clinical - Lupin
Dr.Ravi Sekhar Kasibhatta is currently Sr. Vice President – Clinical Research at Lupin Bioresearch Center, Pune . Previously, held various positions at Dr.Reddy’s Laboratories, Hyderabad; Apl Research Center (Aurobindo Pharma) , Hyderabad; Lambda Therapeutic Research, Ahmedabad; The Nizam’s Institute Of Medical Sciences, Hyderabad.
Dr Kasibhatta completed his Ph.D. in Pharmacology from Dept. of Clinical Pharmacology and Therapeutics of the Nizam’s Institute of Medical Sciences, Hyderabad, India and M.Sc. (Bio-Sciences) from Ravishankar University Raipur, M.P. (Now Chattisgarh), India
Dr Kasibhatta is currently heading Lupin Bioresearch Center to conduct in-vitro & in-vivo BA / BE & Clinical Equivalence Studies for Generic products, PK / PD studies of specialty products like Biosimilar, Inhalations products. He is a Clinical research professional having in-depth knowledge of Clinical, bioanalytical, pharmacokinetic & pharmacodynamics of pharmaceutical domain. Dr Kasibhatta has analytical and problem-solving skills, focussed approach, adaptive to the changing environment and progressive attitude with strong result orientation & timely deliverables.
He is a Team leader & Key member for CRO selection & qualification, cost-effective negotiations for Clinical program of Generic product program. He has proven expertise in establishing CROs, Bioanalytical & Clinical laboratories meeting the ISO standards, ICH-GCP compliance & other applicable international quality / regulatory standards. He is also acquainted with knowledge of latest analytical platforms like LC-MS/MS, IC, ELISA etc., and improved add-on services for Biosimilar, inhalations, derma programs and Biometrics for CT studies. Dr Kasibhatta has published around 33 papers in various national & international journals. He is currently overseeing 03 candidates for Ph.D. in biomedical / analytical sciences.
Medical Director - Abbvie, India
Last assignment as Vice President – Medical, Clinical, Quality Pv& Regulatory Affairs (India & Row), Wockhardt Pharmaceuticals
Published a series of books “prep enhancer” with Jaypee Publishers
Have more than 50 publication in national & international journals
} Previous Clinical associations have been with:
} University of Mississippi, USA; ÀLL India Institute of Medical Sciences, New Delhi; Safdurjung Hospital, New Delhi
Previously worked withMajor Pharmaceuticals organisations like :
• MSD Pharmaceuticals,
• BMS Pharmaceuticals,
• Glenmark Pharmaceuticals
• Menarini Pharmaceuticals
• Emcure Pharmaceuticals
Medical Director - MSD
VP Operations - Intas Pharmaceuticals Ltd. (Biopharma Division)
Sandeep Majumdar is presently associated with INTAS Pharmaceuticals Biopharma div. as VP Operations. In his career spanning over 23 yrs he has worked with various companies like Wockhardt, Sartorius, Reliance life sciences, Biocon and Intas. He has a very versatile experience in projects and manufacturing. He has contributed with his technical and strategic inputs for the successful implementation of the multiple projects. Being in highly competitive and knowledge intensive business his core focus have been to learn and evolve. He has always focussed on Intas’ priority of providing affordable and quality biosimilars.
Director - Office of Therapeutic Biologics and Biosimilars/OND/CDER, US FDA
SI, FRSB, FPAMS, FACB, Founder - Karyo Biologics, Adello Biologics and PharmaSci, Adjunct Professor University of Illinois and University of Houston
Dr. Sarfaraz K. Niazi, teaches how to stay a step ahead of the change in adopting therapies to alleviate human suffering. He advises regulatory agencies including FDA and creates technology to make medicines more accessible. He has authored more than 50 books and has more than 100 patents in the pharmaceutical and biopharmaceutical field. He has taken several products to market and continues to analyze the biosimilar guidance to make it more sustainable and scientifically robust. Dr. Niazi has developed patented testing methods including thermodynamic testing for biosimilarity establishment.
Dr. Niazi has created safety testing protocols for genetic vaccines; developed scale-up of mRNA vaccines and provided advisory to the FDA on evaluating the phase 3 data on COVID-19 vaccines.
Dr. Sarfaraz Niazi is an inductee into the Entrepreneur Hall of Fame for his leadership and raising hundreds of millions of dollars. He is recognized by the Forbes magazine, as "the most interesting man changing healthcare."
Chief Scientific Officer - Apollo Hospitals Educational & Research Foundation, Hyderabad
Senior Vice President,Global Head- Clinical Research, Pharmacovigilance & Medical Affairs - Hetero Drugs
is a senior pharmaceutical physician with over 17 years of experience in Global Clinical Development, Pharmacovigilance, Medical Affairs in Pharmaceuticals & CROs. He is Currently Vice-President and Head- global clinical, medical and pharmacovigilance operations at Hetero group of pharmaceuticals. He is highly experienced in setting up, expanding and operating teams in clinical development, global pharmacovigilance, medical affairs in Pharmaceuticals including Dr. Reddy’s, Hetero, Glenmark, Organon & CROs including Vimta Labs, Alquest LLC. He has also managed end to end clinical development of multiple biosimilars including Darbepoetin, Rituximab, Bevacizumab, Adalimumab and currently ongoing Trastuzumab and a few others at Hetero including domestic and international development & registration.
Product Leader – Research - Cytiva
Principal Application Scientist - Thermo Fisher Scientific
Senior Vice President - Biological E
VP & Head Department of Clinical Research & Biopharmaceutical - Mankind Pharma
Application Scientist - Beckman Coulter Life Sciences
Asia Pacific Regional Biopharma Application, Engineering Leader, - 3M
Executive Director -APAC - Informa Pharma Custom Intelligence
FastTrak Global Training Manager & India Leader - Cytiva
Business Development Manager- Tubing Division - Ami Polymer Pvt Ltd
Sr. Consultant Hemato- Oncologist & Medical Oncologist - Continental Hospital Hyderabad